FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
21695-715
11-digit product format
216950715
Labeler code
21695
Product ID
21695-715_2016f03e-e7ac-43b6-8244-0389ce057b2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA076690
Marketing category
ANDA
Marketing start
2009-09-03
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-715-302019-09-24C16284748780-1934fe258-49aa-48b1-e053-8cdaa90a720aVENLAFAXINE HYDROCHLORIDE TABLETS 0199 7380 7381 7382 7383 Rx only
21695-715-602019-09-24C16284748780-1934fe258-49aa-48b1-e053-8cdaa90a720aVENLAFAXINE HYDROCHLORIDE TABLETS 0199 7380 7381 7382 7383 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-715-30Venlafaxine Hydrochloride30 in 1 BOTTLETABLET302
21695-715-60Venlafaxine Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-715-30EA - Each21695-7155c04f504-505e-4004-a30a-7189cf37f7f512012-07-24
21695-715-60EA - Each21695-715f869ce8b-ae8b-4f8e-ab7e-24c7bc771ecd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-715VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 2 package rows20111227_49bef388-71ff-43b1-87a8-9fd506a0e63e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN49bef388-71ff-43b1-87a8-9fd506a0e63e2
313582venlafaxine HCl 25 MG Oral TabletPSN49bef388-71ff-43b1-87a8-9fd506a0e63e2
313584venlafaxine HCl 37.5 MG Oral TabletPSN49bef388-71ff-43b1-87a8-9fd506a0e63e2
313586venlafaxine HCl 75 MG Oral TabletPSN49bef388-71ff-43b1-87a8-9fd506a0e63e2
313580venlafaxine 100 MG Oral TabletSCD49bef388-71ff-43b1-87a8-9fd506a0e63e2
313582venlafaxine 25 MG Oral TabletSCD49bef388-71ff-43b1-87a8-9fd506a0e63e2
313584venlafaxine 37.5 MG Oral TabletSCD49bef388-71ff-43b1-87a8-9fd506a0e63e2
313586venlafaxine 75 MG Oral TabletSCD49bef388-71ff-43b1-87a8-9fd506a0e63e2
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY49bef388-71ff-43b1-87a8-9fd506a0e63e2
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY49bef388-71ff-43b1-87a8-9fd506a0e63e2
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY49bef388-71ff-43b1-87a8-9fd506a0e63e2
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY49bef388-71ff-43b1-87a8-9fd506a0e63e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-715-302169507153030 in 1 BOTTLEHistorical
21695-715-602169507156060 in 1 BOTTLEHistorical